MPN NA Issue 9

NORTH AMERIC AN EDITION

MEDICAL PLASTICS news A so p p ft a r o

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HOW SOFT TOUCH PLASTICS ARE ENABLING USABILITY

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SPOTLIGHT ON DRUG DELIVERY FEMTECH IN FOCUS 40 YEARS OF PEEK

ISSUE 9

Jan/Feb/Mar 2019

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ADVANCING MEDICAL PLASTICS

CONTENTS MPN North America | Issue 9 | Jan/Feb/Mar 2019

Regulars

Features

3 Comment Dave Gray explores the changing nature of the medtech-pharma relationship

20 A brave new world 3M on the digital revolution in drug delivery 25 Finish the job Microcare examines the way that miniaturization is affecting coatings

4 Analysis 6 Digital spy 11 The year ahead Our forecast for the sector in 2019, plus, some hardlearned lessons from 2018

32 Film stars Q&A – what Tekni-Plex’s latest extrusion acquisition means for the business 35 The Anaheim mighty… medtech show Dave Gray’s highlights and must-sees at MD&M West

28 Yet to PEEK To celebrate 40 years of PEEK, MPN chats to Invibio about the history of the material

14 Cover story Trinseo talks innovation for self-care 36 Back to the Future

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CREDITS

EDITOR’S

group editor | dave gray

comment

head of content | lu rahman contributor | reece armstrong assistant editor | ian bolland advertising | sarah livingston head of media sales plastics & life sciences | lisa montgomery head of studio & production | sam hamlyn graphic design | matt clarke publisher | duncan wood Medical Plastics News NA Print subscription - qualifying criteria US/Canada – Free UK & Europe – £249 ROW – £249 Medical Plastics News Europe Print subscription - qualifying criteria UK & Europe – Free US/Canada – £249 ROW – £249 FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2018 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

ISSN No:

2047 - 4741 (Print) 2047 - 475X (Digital)

May cause unintended side effects

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e’ve written a few times this year about the interplay that exists between medical devices and pharma. With advances in digital drug delivery, and the use of wearables in clinical trials, that close bond is only set to get stronger.

But there’s also a new trend emerging as part of this cooperation: medical devices for reversing the side effects of the pharmaceutical business.

For example, I read recently that the FDA has selected eight medical device firms to work on solutions to try and bring the opioid crisis to an end. As part of its Breakthrough Devices programme, the agency will work closely with the eight firms to expedite the arrival of their technologies on the market. These companies were whittled down from over 250 applicants, all seeking to try and reverse what can be reversed of the damage caused by certain drugs and their dispensation.

According to the FDA, it is trying to help scale up and commercialize either devices which can identify those vulnerable to addiction, or devices which can manage pain

as an alternative to medication.

One of the winning entrants is iPill Dispenser, which uses a biometric app to help reduce overconsumption by dispensing pills based on prescriptions.

It’s not the first time in recent months that the FDA has turned to medical devices to counteract the unintended consequences of our dependence on drugs. Back in September, FDA commissioner Scott Gottlieb outlined the agency’s collaborations with innovators working on diagnostic devices to identify resistant strains of bacteria.

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It’s not the first time that the FDA has turned to medical devices to counteract the consequences of our dependence on drugs

“Coordinated product development between drug and device developers can be very effective in streamlining the regulatory pathway. Such coordination has resulted in antimicrobial susceptibility devices being available almost immediately or within weeks of three recent new drug approvals.”

- Scott Gottlieb It seems that a new avenue may be opening up for medical device OEMs, an avenue which is intrinsically linked to the pharmaceutical sector, but not in the way we’ve come to expect.

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NEWS ANALYSIS

WHY IN-HOME HEALTHCARE IS GOOD NEWS FOR PLASTICS TIM JENNINGS, PRESIDENT OF CUSTOM CASE GROUP, A MANUFACTURER OF CASINGS FOR THE BIOTECH INDUSTRY AMONG OTHERS, EXPLAINS WHY THE TREND TOWARDS IN-HOME HEALTHCARE IS SET TO BENEFIT THE PLASTICS INDUSTRY.

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hundred years ago, most doctor visits took place in the patient’s home. But by the 1940s, population growth in urban areas and advances in medical technology made office visits more efficient and effective for both doctors and patients. By the 1960s, the vast majority of doctor visits occurred in healthcare settings, enabling doctors to see more patients in a single day and ensuring easy access to the latest medical equipment. But in the last decade, this trend has slowly begun to reverse; and the healthcare industry – and as a result, the medical plastics sector – will benefit.

At first, the reemergence of in-home healthcare seemed like a premium service that only the wealthy could afford. But recent findings suggest the opposite: In-home healthcare might actually cost less in the long run than in-office healthcare.

One of these findings came from the Independence at Home Demonstration (IAH), developed by the Centers for Medicare & Medicaid Services in 2012.

The program, which aimed to evaluate the efficiency and effectiveness of at-home medical care, focused on 10,000 Medicare patients with chronic illnesses. 17 independent medical practices were assigned to these patients, and each practice was required to provide primary care at home, maintain a mobile electronic health record for each patient, and visit patients within 48 hours of emergency room or hospital discharge.

Overall, the Centers for Medicare & Medicaid wanted to determine the quality of at-home care; whether or not it improved patient experience; and if it could potentially reduce Medicare costs by decreasing ER visits, hospitalizations and 30-day readmission rates. In the first two years of the program, all of these metrics were met. ER visits, hospitalizations and 30-day readmission rates declined; patients reported greater satisfaction; and Medicare costs declined by 30% – or more than $35 million in savings. If expanded, a nationwide IAH program could save up to $15 billion over the next decade.

same day, while established medical centers, healthcare practices and insurance companies are beginning to incorporate at-home care into their offerings.

For those of us in the medical plastics industry, these findings suggest that as mobility and convenience become primary factors in healthcare delivery, portable medical places will play a crucial role in the future of our business. In fact, PME is already a sizeable business; in 2017, it generated $27.8 billion globally.

Experts think that PME demand is only going to increase – some estimates predict upward of $50 billion in revenue by 2024 – thanks in part to aging populations living longer and an increased emphasis on quality of life.

Lightweight, durable and costeffective, medical plastics will be the touchstone for the new era of modern mobile healthcare. Make sure you’re leading the pack.

The IAH demonstration is one of a number of studies with similar results. In 2017, researchers from Indiana University’s Center for Aging Research and the Regenstrief Institute found that people who received in-home healthcare after being discharged from a skilled nursing facility were less likely to be readmitted to the hospital within 30 days than patients who visited an outpatient provider after discharge.

Across the medical industry, companies are taking notice of these findings and investing accordingly.

Start-up, consumer-facing apps like Heal allow patients to book in-home healthcare visits the

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Learn more at www.dow.com/medicalsolutions

DIGITAL

spy

www.fostercomp.com Foster Corporation appointed North America distributor of Solvay polymers

3D PRINTING www.tmh.org

US-UK project brings 3D printing to neurosurgical procedures

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greater understanding for our patients.”

Tallahassee Memorial HealthCare (TMH) which operates in North Florida and South Georgia, and UK-based axial3D will collaborate to deliver medical printing services with an initial focus on neurosurgical services.

Plans to expand across other surgical specialities in the organization will follow. As axial3D’s first and only neuroscience industry partner in the United States, TMH will collaborate with other international partners to collate data on the use of 3D printing in neurosurgery, and participate in groundbreaking research and complete case studies, from both the clinical and business perspective.

Mark O’Bryant, president and CEO of Tallahassee Memorial HealthCare said: “At Tallahassee Memorial HealthCare, we have a commitment to bringing the best patient care to our community, this includes identifying, vetting and introducing new technology.

Our neurosurgery program is already the leader in the region and the opportunity to introduce 3D printed models adds a new dynamic to the program that can lead to better outcomes and

Matthew Lawson, MD, neurosurgeon at TMH added: “Much of what we do in neurosurgery is 2D. Being able to utilize a 3D model and hold it in your hands prior to surgical intervention is very insightful for the patient – it helps them understand surgical interventional risks and benefits. 3D models have been shown to increase patient consent rates and aid in patient understanding of the planned procedure.”

wo medtech firms have announced a new partnership designed to enhance patient outcomes by delivering a transformative approach to pre-surgical care through the use of 3D printing.

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MATERIAL UPDATE

Foster Corporation has been appointed as a North American distributor of Solvay’s KetaSpire PEEK and AvaSpire PAEK polyketone based polymers.

This will include unmodified polymers and standard color formulations currently offered by Solvay.

Foster is currently a distributor for Solvay’s Radel polyphenylsulfone (PPSU), Udel polysulfone (PSU), and Ixef polyarylamide (PARA) in the North American healthcare market.

PEEK and PAEK medical grade polyketone based polymers are high flexural modulus and high strength polymers that offer extreme heat resistance and excellent hydrolytic stability. They maintain their mechanical properties in reusable applications when exposed to multiple steam sterilization cycles as well as other sterilization techniques.

Both polymers can withstand over 1,000 steam sterilization cycles without significant loss of properties, as well as biocompatible (USP

Class VI and ISO 10993) and biostable.

Larry Johnson, executive vice president at Foster Corporation said: “Solvay’s standard grades of PEEK and PAEK polyketone based polymers, along with their sulfonebased polymers, are in high demand for reusable medical devices. Additionally, device companies are increasingly evaluating material formulations that provide differentiated colors and performance characteristics.”

DIGITAL UPDATE www.advamed.org

How US medtech OEMs are navigating digital transformation America’s medtech giants are adopting a variety of strategies to navigate the changing healthcare ecosystem, according to a new study from the Deloitte Center for Health Solutions and the Advanced Medical Technology Association (AdvaMed).

The new study, “The next wave of innovation: Technology and value-based care are transforming medtech R&D,” details how a growing emphasis on value-based care models and new technologies are influencing medtech companies’ business strategies.

It found to adapt to healthcare system transformation, R&D executives are prioritising diversifying portfolios, accelerating time to market and leveraging real world evidence in product development.

“A changing healthcare landscape is creating new opportunities for medtech to drive innovation, and medtech is certainly taking advantage,” said Scott Whitaker, president and CEO of AdvaMed. “R&D leaders are shifting their strategies in the face of new trends to boost efficiency, reduce costs, and provide more integrated

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and coordinated care for the benefit of patients around the world.

AdvaMed will continue to promote policies that support this evolution, so that medtech can continue to deliver life changing treatments and cures.”

All companies surveyed in the study reported investing in device connectivity; however 77% identified integration of data from new technologies as a potential obstacle, citing lack of access to critical funding and skill gaps. Additionally, 95% of companies surveyed pinpointed increasing complexity of global regulatory requirements as a major challenge.

DIGITAL SPY

DIGITAL UPDATE

regulatory

UPDATE www.kcl.ac.uk

Catheter ablation made more successful thanks to computer modeling New computer models that simulate the workings of individual patients’ hearts could boost treatment of a common cardiac condition that affects millions of people worldwide.

A team at King’s College London has taken the first steps in developing models designed to optimize a procedure that corrects atrial fibrillation, a condition which causes abnormal heart rhythms.

The new models aim to increase the effectiveness of catheter ablation by making it possible to explore, in advance, different strategies for its use geared to the specific needs of individual patients.

Every year, around 10,000 people in the UK have a catheter inserted in order to treat atrial fibrillation using radiofrequency energy. But the procedure is not always effective, there is a small risk of it causing a stroke or death, and the condition often recurs.

Developed using skills in computational modeling, software development and image processing, and based on detailed data about the patient’s heart obtained through medical imaging, the models depict tissue condition and blood flow, and enable simulation of around 10 cardiac cycles lasting a few seconds in total.

HEALTHTECH UPDATE

www.abhi.org.uk

everything is bigger in texas Clinical trials, research collaborations, new partnerships and sales are all outcomes from the Association of British HealthTech Industries’ (ABHI) work in Texas.

At the end of 2018, a cohort of British healthtech companies and medical institutions took part in the tenth mission to Texas to showcase medical devices, diagnostic software and digitally-enabled technologies.

Companies met with hospital system leaders, GPOs, distributors, clinical leaders and procurement teams across Dallas-Forth Worth, Houston and Austin.

This included chief medical directors and senior leadership teams from a range of hospital systems.They also had a productive session with the medical director and human health performance diporate at NASA.

Another highlight of the week was the discussion panel at The Dell Medical which featured a range of key UK figures from the healthcare sector, talked about innovative pathways, health systems and the delivery challenges in relation to both the UK and the US.

www.fda.gov FDA SELECTS EIGHT MEDICAL DEVICE FIRMS TO HELP TACKLE OPIOID ADDICTION Eight medical device firms have been selected by the Food and Drug Administration (FDA) to help prevent and treat opioid use disorder.

Over 250 applications entered the FDA’s Innovation Challenge. The challenge was intended for diagnostic or therapeutic medical devices, including mobile medical apps that help prevent and treat opioid addiction. The products from the eight companies selected include those intended to predict the risk of opioid addiction, detection, dispense medication and provide pain treatment alternatives to opioids.

The regulator will work with the chosen companies and products to accelerate the development and expediate marketing application review, with Breakthrough Device designation granted to devices that meet the statutory criteria without the need of a separate application.

In a statement on the regulator’s website, Jeff Shruen and Jonathan Jarow said: “We believe the greatest opportunities for medical devices to help prevent opioid use disorder are devices that could help identify people likely to become addicted, devices that manage pain as an alternative to opioids or reduce the need for opioid medications.

For example, the development of a diagnostic device, whether it be an in vitro diagnostic test, software or a mobile medical app, could be highly impactful in identifying those patients for whom extra caution should be exercised when prescribing opioids for acute or chronic pain.

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OPERATIONAL EXCELLENCE IN MANUFACTURING

MANUFACTURING REDEFINED. At Freudenberg Medical, operational excellence is a mindset, an approach and a philosophy to continuously improve product quality and the efficiency of our processes and services. Our customer-centric manufacturing transfer process ensures that needs and expectations are explicitly documented, translated into requirements, and project plans are executed on-time and within budget. From next-generation designs, enhancements to production, and scale up for volume manufacturing.

CATHETERS. COMPONENTS. COATINGS. freudenbergmedical.com

NEWS ANALYSIS

DIAGNOSTIC DUOS MIRANDA CONARY, PRODUCT SPECIALIST AT WEB INDUSTRIES, DISCUSSES HOW DEVICE MAKERS AND CONTRACT MANUFACTURERS COLLABORATE FOR SUCCESS IN DEVELOPMENT OF MEDICAL DIAGNOSTIC DEVICES.

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n today’s fast-moving medical device industry, original equipment manufacturers (OEMs) are increasingly turning to resources outside of their four walls to bring products to market. The reasons why they choose to collaborate with contract manufacturers vs. go it alone are as varied as the businesses themselves, but a few drivers include: •

•

• •

Bridging capability gaps. Perhaps a start-up has strong new product ideas but little experience with product development and the path to commercialization. Or a device maker lacks a biochemistry lab or quality control team experienced in lateral flow immunoassay (LFI) devices.

Optimizing high-speed, high-volume automation.

A contract manufacturer may have machinery to handle very wide material rolls or robotic assembly lines to eliminate manual labor.

Qualifying a secondary supply source to mitigate risk in case a primary supplier reaches capacity or has a production interruption.

Accessing a more extensive supplier network, presenting the chance to use novel and different materials supplied in diverse formats.

DEVICE MAKER-CONTRACT MANUFACTURER RELATIONSHIP: STEP BY STEP Every contract manufacturing relationship is different.

In some situations, a device developer may turn to a converter to perform a single but specialized process, such as supplying a pad material with a deposition on it.

In other cases, a contract manufacturer may be engaged with the device developer from the very earliest design phases all the way through to commercial-scale production and packaging. Regardless, there are some common steps in the collaborative process.

PROJECT DEFINITION PHASE: During this step the device developer and contract manufacturer typically conduct a technical meeting to review the product, its status in the development process, documentation, studies that are completed or underway, the desired timeline and any forecasts for

anticipated volume. There are advantages to involving a contract manufacturing partner as early as possible in the development process. The contractor can weigh in regarding design or raw material changes that could be made to significantly enhance manufacturing efficiency and speed. For example, if the device developer’s pad material supplier only provides 50-meter rolls, and the converter’s operations can support 100-meter rolls, it makes sense for the device developer to take advantage of the larger batch sizes possible with using larger rolls. Such issues often rise to the surface during the project definition phase. From this phase, the OEM usually receives a full report from the contract manufacturer outlining an estimated project timeline, preliminary pricing, risk assessment and point-bypoint review of how the project will flow through its operations.

TECHNICAL TRANSFER PHASE: During this phase the contract manufacturer presents the device OEM with a more formalized project plan and starts conducting activities such as raw material supplier assessments, engineering studies and equivalency testing. Equipment is calibrated to deliver products within precise specifications, and the partners continually verify and validate results every step of the way. As with the other two phases of development, this should be a stage-gated process in which the partners pause at each gate to evaluate how things are going and are free to walk away if the relationship is not satisfactory.

COMMERCIALIZATION PHASE: During this stage, the OEM and contractor enter into formal supply agreements, nail down quality requirements for the commercial-scale production and start manufacturing devices for sale to the market.

In conclusion, throughout the device development process there must be communication, trust and transparency between a device OEM and its contract manufacturing partner. These qualities and a strong spirit of adaptive engineering go a long way toward ultimate product success.

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THE YEAR AHEAD

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critical mass AS WE BREAK INTO THE NEW YEAR, WHAT DOES 2019 HAVE IN STORE FOR MEDTECH? DAVE GRAY LOOKS AHEAD.

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t’s been said many times before that progress is gradual in the medical device sector. Nevertheless, we’re still living and working through a transformative moment in healthcare delivery, where the aging population, rising costs, obesity, diabetes and cancer are coming together in a critical mass, and blustering the sector’s innovators into action.

M&A: IS IT ALL JUST WHISPERS? At the time of writing, there’s not a lot to say with regards to mergers and acquisitions, except that based on the last couple of years, we can expect to see more seismic shifts in the market – but where they will come from is anybody’s guess. But, full disclosure, I’m writing this in 2018, trying for once to get ahead. So, by the time this lands early in 2019, Apple, Amazon and Google may well be at the head of the medical device table, with only a couple of hopefuls watching from the sidelines. Only joking. Sort of.

That said, there is speculation about some big plays that would seriously rock the boat in 2019 if they ever came into fruition. Probably the most significant here would be those whispers about J&J’s potential interest in either Boston Scientific, or perhaps one of its rivals, Edwards. This story stemmed from a report in US paper Barrons in late summer 2018, which suggested that such a move would come with the aim of making inroads into the field of transcatheter heart valves. But this sort of rumor is rife after a period of aggressive acquisitions from most of the key players – maybe we will see another super takeover in 2019, but for now, it’s merely speculation.

One deal that looks a lot more likely to close in 2019 is Boston Scientific’s agreed offer to acquire UK firm BTG – a player in minimally-invasive technologies for oncology. Subject to regulatory approvals, the deal is scheduled to close in the first half of the year.

“The acquisition of BTG and its rapidly growing peripheral interventional portfolio is an exciting extension of our category leadership strategy that will augment our capabilities in important areas of unmet need such as cancer and pulmonary embolism,” said Mike Mahoney, chairman and chief executive officer, Boston Scientific.

“We are confident that the addition of these therapies to our portfolio will ultimately advance patient care in ways that could not be realized by either company alone, while also allowing us to realize substantial revenue and cost synergies and provide a strong return for investors.”

LESS IS MORE If you really want to see change happening year-on-year, probably the best way is to attend Compamed and Medica. The last couple of years have definitely demonstrated increased prevalence of miniaturized technologies, driven in part by the wearables and diabetes markets. One innovator in this field is Jaume Palau, creator of sleep apnoea device Airmony.

Writing for Med-Tech Innovation News recently, Jaume believes the trend towards miniaturized devices and portability will be most emergent in six key areas: ECG monitors, glucose monitoring systems, blood pressure monitors, continuous positive airway pressure (CPAP) devices, air quality monitors, and massage devices.

“With the rise of portable medical devices and the proliferation of smart home technology, people are

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THE YEAR AHEAD

now increasingly able to live with their conditions at home and look after their own health as they travel.”

All of this innovation impact on material choice, and material combinations, too. According to Nigel Flowers, MD at injection molding machinery supplier Sumitomo Demag UK, “almost every material you would expect in medical could crop up in micro molding – there is no specific material of choice for implantable devices. It is dependent on what the part is being used for – there have been cases where the plastic is coated in gold for some cancer treatments.”

DO-IT-YOURSELF HEALTH The trend towards self-care is another factor set to impact manufacturing choices in 2019. Especially in applications for the elderly, disabled, and pediatric care, we’re likely to see more examples of rigid plastic components with soft touch, grippable materials overmolded on the outside. This trend draws on the principles of human factors design. Where more and more drug delivery or monitoring devices are intended for home use by the patient, designers are choosing outer materials which simple operation.

IT’S HOW YOU PACKAGE IT THAT COUNTS It’s official: smart packaging is here. We’re seeing it in every industry, not just medical, and its emergence goes hand in hand with stricter global regulations on goods and services. Intelligent ink has seen increasing usage in medical applications, but I expect that the coming years will propel advanced printed electronics to the fore of medical device packaging.

The August Faller Group for example recently announced a prototype of a ‘counting device’ – a folding carton for medicine which uses an e-paper display and electronic controls. The user just has to press a button on the display each time he/she takes a pill, and the packaging can track their dose. Another prototype from the firm, currently just called ‘Medical Prescription’ keeps track of the amount of pills and connects to a smartphone app via bluetooth, which in turn sends the signal to order a repeat prescription. At what point does medical packaging and drug delivery become one and the same? It can’t be far off.

The other news, which will be welcome to certain manufacturers, is that the FDA has issued an extension to the compliance deadline for certain aspects of Unique Device Identification (UDI). Manufacturers of certain non-sterile, class I, and unclassified devices will now have until 24th September 2020 to comply with standard date formatting, labeling and Global Unique Device Identification Database (GUDID) data submission requirements. According to Medical Design and Outsourcing, the move was a response to concerns that manufacturers might simply dispose of non-complying inventory rather than undertake costly revisions, thus leading to supply shortages for patients.

EMERGING MARKETS Asia continues to be the land of promise for many Western medtech players. The question is, do we still need to refer to Asia’s territories as ‘emerging markets’? China, in particular, looks set to be center stage in 2019 as a key prospect.

A recent announcement from the Chinese ministry of health stated that the country will issue licenses for 154 new surgical robots by the end of 2020. This news sends a clear message – China wants its healthcare provision to be the best and most innovative it can be. After all, surgical robots are still in their (relative) infancy, and automated procedures are not cheap to perform – particularly in countries with massive populations.

But despite the perceived drawbacks of the technology, China’s announcement sent stocks in Intuitive Surgical (the maker of the da Vinci robot assisted surgical system) up by 6.6%. It seems that not only is China continuing to shine in medtech, the country is now targeting the big ticket items – something to consider.

A POSITIVE START There are plenty of reasons to be optimistic about 2019 – not least the unusually fast pace of change in the innovator sphere. And in terms of the calendar, it all kicks off in Anaheim in February, where we’ll be on-site at MD&M West. Then, in May, we look forward to welcoming you to the NEC in Birmingham, UK – the new home of our very own Med-Tech Innovation Expo, which this year promises to be more international than ever.

FEMTECH Femtech is an increasingly prevalent term, but more work is needed to make it a pervasive field within healthcare. Don’t be fooled into thinking that it applies only to ‘female’ health problems either. Femtech encompasses an unbiased approach to medical device design, which I believe we can expect to see more of in 2019. In a recent article, Forbes points out for example that Zimmer Holdings has a gender-specific solution for its high-flex knee prosthetic, the design of which acknowledges the anatomical differences in women’s and men’s knees that need to be catered to while making prosthetics.

That said, the last few years have seen a surge of female-led enterprises launching new tech specifically for women’s health, and that trend, too, is set to continue. What’s needed, however, is support from the VC, accelerator and adoption communities. Forbes claims that ‘women’s health accounts for only 4% of the overall funding for research and development for healthcare products and services’ – that cannot be good enough for 50% of the population. Let’s hope that 2019 will bring investment into this vital field.

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COVER STORY

Manufactured for being human

TRENDS IN HEALTHCARE CREATE DEMAND FOR SOFT-TOUCH OVERMOLDING Plastics play an important role in the medical devices industry. Not only do they help control cost (e.g., light weighting and parts consolidation), they’ve improved patient care (e.g., non-invasive surgical devices), and contributed to patient safety (e.g., glass replacements). Now plastics are assuming an even greater role as manufacturers realize that rigid, hard-touch surfaces can benefit from a soft-touch feel.

Overmolding is the solution that’s emerged and it’s becoming quite commonplace. Through co-injection or insert-molding, a thermoplastic elastomer (TPE) overlay is created to enhance an application’s surface.

Overmolding is used to differentiate products. It improves ergonomics and makes products safer. Automakers have known the importance of overmolding as a way to create a luxurious feel for high-end customers.

Houseware manufacturers have been attuned to the ergonomic implications. Consumer electronics companies have known the added value that comes with color or texture.

“Overmolding can be found in a wide range of healthcare applications ranging from surgical and dental instruments to wheel chair grips to drug delivery devices to medical wearables,” said Aldo Zanetti, business manager for Trinseo’s medical TPE business. “The demand for the overmolding process is being driven by several trends – a move toward home healthcare, growth in self-administered treatments, and an overall aging population.”

Zanetti notes that the U.S. Food and Drug Administration (FDA) may have contributed to the interest in overmolding. The FDA recently issued a guidance document called “Applying Human Factors and Usability Engineering to Medical Devices” (revised February 2016). The intent of this report is to encourage manufacturers to make sure their devices can be used safely, without causing harm or lessening the effectiveness of treatment.

Trinseo has been a leading supplier of rigid thermoplastics for medical devices for decades. Now, to better support the healthcare industry, the company has added thermoplastic elastomers (TPEs) to its portfolio though a 2017 acquisition of Italian manufacturer API S.p.A, which has specialized in the research, development and production of soft polymer compounds for more than 60 years.

Trinseo is announcing its expanded portfolio of plastics for medical device applications offering global manufacturers and molders rigid and soft-touch plastics that have been known and trusted for decades. As a manufacturer of both the TPE and the rigid substrate, Trinseo says it has full control of the chemistries of both the materials enabling it to provide optimal adhesion. Trinseo plastics for medical are as follows: Rigid plastics (thermoplastics) • CALIBRE polycarbonate resins • CALIBRE MEGARAD polycarbonate resins • EMERGE advanced resins • MAGNUM ABS resins • STYRON polystyrene resins Soft-touch plastics (thermoplastic elastomers) • MEGOL MED TPS-SEBS compounds • MEGOL SK TPS-SEBS compounds • RAPLAN MED TPS-SBC compounds

COVER STORY

A LOOK AT THE DRIVERS OF DEMAND HOME HEALTHCARE As healthcare services move from traditional settings such as hospitals, clinics, and physician’s offices to nonclinical and personal living spaces, people want medical equipment that blends in with their surroundings. The use of TPEs provides aesthetically pleasing, soft-touch surfaces to help devices look more attractive and less institutional. They also offer benefits such as reduced vibration and noise as well as soft-touch, easy-to-grip knobs and handles that can improve functionality for professionals familiar with medical equipment and those who are not.

SELF-ADMINISTERED CARE Patients want convenient, effective treatment that can be administered “on the go.” This has created a need for drug delivery devices such as auto injectors, asthma inhalers, and portable respiratory equipment. Along with the actual device, is a need for easy administration and error-free performance. Part design and/or textured surfaces can help guide proper handling. Colored inserts or molded-in labels can provide instruction and non-slip grips can help ensure accurate administration.

AGING AND SPECIAL NEEDS POPULATIONS According to the World Health Organization (WHO), the number of people 60 years or older will jump from 900 million to two billion between 2015 and 2050.

Medical device OEMs need to adjust to this growth by developing devices that take a variety of factors into consideration. Not only is age of the patient important, but physical dexterity, flexibility, and coordination are all key as manufacturers work to create ergonomic designs for patients of all types and abilities.

OVERMOLDING EXPLAINED Overmolding is an injection molding process in which a thin TPE layer is applied to a second material, or substrate, typically a rigid plastic. The substrate can either be non-polar, a polypropylene (PP), or polar, either a polystyrene (PS), acrylonitrile butadiene styrene (ABS), polycarbonate (PC) or PC/ABS blend. And, the actual TPE chemistry type used to create the overlay – and there are six classified TPE categories according to ISO 18064 standards (TPS, TPO, TPV, TPU, TPC, or TPA) – depends on the substrate material.

The most important element in overmolding is good adhesion of the TPE onto the thermoplastic, in other words, bond strength. Due to the wide variety of TPE types and the large number of cross-industry manufacturers using the technology, reaching qualitative, quantitative, and comparative consistency regarding bond strength has been difficult.

The automotive industry has led the way in the use of overmolding and, in the last three decades, the industry’s demand for combining soft TPEs with hard materials has increased. Today, more and more

applications require a soft, rubbery-touch surface to cover rigid substrates and as a result, the industry had been using various test methods to determine the quality of adhesion.

In 2008 in an effort to develop overmolding standards, the Association of German Engineers embarked on an initiative to define a common testing protocol. The automotive-industry-driven initiative focused on creating an international standard to define bond strength, with the aid of a systematic peeling-test procedure. The resulting “VDI 2019 Standard” has been developed and is now applicable to TPE testing on any rigid thermoplastic material. It also includes specifications for required documentation.

Central to the VDI standard is a Peeling Test, which measures the quality of the adhesion. In essence, a dynamometer measures the resistance of the materials to separation. In a controlled environment the soft components are subjected to constant tensile stress until failure, and then fracture patterns are assessed and the type of fracture provides an indication of the strength of the bond.

According to Zanetti, the importance of testing during the application design process is critical and, by adopting this discipline, product manufacturers can realize the benefits of reduced cycle time and cost in final production.

“In the course of testing, if a molding sample doesn’t meet quality standards, several possibilities exist,” said Zanetti. “Bond strength can be improved by either modifying the injection molding variables or the chemical formulation; better bonding can also be achieved through changes in the TPE polymerization process.

“A total system solution approach to problem resolution is essential, meaning it’s important to look at the rigid material in combination with the TPE, particularly if adjustments need to be made to the materials simultaneously. This is the best way to achieve optimal adhesion, which is especially critical in the medical devices industry where the final application ultimately impacts patient comfort, satisfaction, or safety.”

Trinseo’s Specialized Overmolding Testing Center (SOC) in Mussolente, Italy is dedicated to overmolding excellence and has been fulfilling the requirements of VDI since 2014. The SOC is equipped with a stateof-the-art laboratory designed to measure bond strength and determine adhesion in relation to main injection molding variables: material temperature, mold temperature, injection speed, injection pressure, and post injection pressure. Trinseo, then API, contributed to the writing of the VDI standard.

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medtech | digital healthtech | medical plastics manufacturing | software | inspection and metrology regulation | design | early stage innovations pharmaceutical manufacturing

MED-TECH INNOVATION

EXPO

#MedTechExpo @medtechonline

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15-16 FREE TO ATTEND 200+ EXHIBITORS 4,000+ ATTENDEES 3 CONFERENCE STAGES REGISTER NOW

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2019

MAY

NEWS ANALYSIS

2019: TIME TO BRING YOUR A-GAME REGULAR CONTRIBUTOR REECE ARMSTRONG LOOKS FOR THE POSITIVE REPERCUSSIONS IN WHAT TURNED OUT TO BE A CHALLENGING PAST YEAR FOR THE MEDICAL DEVICE SECTOR.

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hen news that millions of patients across the globe had suffered serious side-effects due to medical devices, it seemed like a long time coming.

After all, stories on patients experiencing life-changing effects due to devices such as surgical mesh, contraceptives and pacemakers have been circulating for years.

The Implant Files highlighted the scale of the issue though and showed the regulatory cracks and loopholes through which ‘faulty’ or ‘poorly-tested’ devices have reached the market and ultimately patients.

If anything the investigation, which includes an analysis of over eight million medical device records, highlights to the public the potential dangers that devices designed to save or improve lives can bring with them. Public awareness over the safety of medtech products is inarguably important, especially when information regarding the risks posed by devices has been limited to both patients and doctors.

The response from the medtech industry was mixed, with certain groups such as the Advanced Medical Technology Association (AdvaMed) stating stories from the Implant Files “counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide.”

MedTech Europe took issue with the investigation’s view on how the industry works, iterating that “every day millions of people benefit from medical devices,” but that it has “always supported a regulation that better serves patients and provides a predictable, sustainable and appropriate regulatory environment.”

Perhaps then more of the blame should be directed at regulatory agencies including the Food and Drug Administration (FDA) and Europe’s notified bodies.

In particular, the FDA’s 510(k) process has come under strong criticism due to the way it can ‘fast-track’ medical devices to market on the basis of equivalence.

This means that if a medical device manufacturer can demonstrate its device is as safe and effective as another predicate device already on the market, then it doesn’t have to undergo clinical trials.

Fortunately the FDA seems to have responded to criticisms regarding the 510(k) process and has announced new steps to ‘modernize’ the premarket programme.

Going forward, the FDA will introduce an alternative premarket approval system that aims to do away with the focus on predicate devices. In particular, the organization will remove devices that are more than 10 years old as a basis for safety equivalence.

This new “Safety and Performance Based Pathway”, is being touted by the FDA as a transparent approach for classifying the safety and effectiveness of low to moderate risk devices.

In response to the modernized 510(k) pathway, president and CEO of AdvaMed, Scott Whitaker, said: “While we believe the 510(k) pathway has proven its effectiveness over the years, we have always maintained that any process can be improved, and we stand ready to work with FDA and all stakeholders toward the shared goal of enhancing the current review paradigm. We look forward to learning more about the agency's plans to implement an alternative 510(k) pathway and to encourage the use of more recent predicates.”

Hopefully the medtech industry responds positively to the FDA’s new changes but what’s most important is that the regulatory updates benefit patients in the long run. So far, announcements made by the FDA in regard to post-market surveillance and women’s health products, including gynecological surgical mesh, appear to be genuine in concern to the efficacy of these devices.

The medtech industry has always been a bastion for medical innovation but ignoring the global cry of patients threatens its very foundations. Let’s hope then that the Implant Files investigation represents a landmark moment for the regulation of medical devices all across the world.

Speaking about this decision, FDA commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health, commented: “We believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes.”

Additionally, in 2019 the FDA hopes to finalize guidance on its alternative 510(k) pathway which will be based on safety and performance criteria. The FDA’s terminology is vague, pertaining to manufacturers of certain “well-understood” devices, but it essentially boils down to a set of guidelines through which predicates which will be based on to support new devices.

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Where you need us, when you need us Sterigenics® is the global leader in sterilization solutions with more than 90 years of deep expertise and operations that span 47 facilities in 13 countries.

We work with you from product conception to commercialization, helping to ensure the safety of your Medical Device Product and Process.

Safeguarding Global Health™ - with every product we sterilize.

Visit us at Booth #3029

THE FUTURE OF HEALTHCARE PRODUCT STERILIZATION THE PERSPECTIVE OF A CONTRACT SERVICE PROVIDER

sterigenics.com

Kevin O’Hara | February 5, 12:30 | Tech Theater Sterigenics® is a registered trademark of Sterigenics U.S., LLC. All rights reserved. © December 2018, AC105.0108(12/18)

MEDTECH JAPAN

Let’s get together MEDTEC JAPAN IS PART OF A SERIES OF EVENTS TAKING PLACE IN MARCH 2019 FOR THE COUNTRY’S LIFE SCIENCE COMMUNITY, AND ITS ORGANIZERS ARE HOPING TO DRAW A SIZEABLE INTERNATIONAL CROWD.

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sia’s largest exhibition and conference dedicated to the Medical Device Design and Manufacturing industry, Medtec Japan 2019 will be held in Tokyo from 18-20 March 2019.

Over 560 exhibitors from 25 countries around the world exhibited their latest technologies and services last year in Japan, which is the second largest medical device market in the world after the United States. With a rapidly aging population and rising demand for increasingly sophisticated treatments, the medical devices industry is one of the few that has seen continuous and steady growth.

Over 31,000 visitors attended the previous event from nearly 30 countries, including the United States, Europe, ASEAN countries, China, Korea and many more. Medtec Japan is a highly targeted event, with over 60% of visitors coming from medical device manufacturers. Among them are buyers and R&D staff from numerous companies comprising the top industry players.

Medtec Japan is co-located with five other exhibitions: ELECTROMED JAPAN Exhibitors include experts in the fields of: semiconductors, ICs, sensors, processors, EDAs, laser technologies, batteries, power adapters, cameras, Lenses, monitors, MEMS technology, graphics interfaces, motors, communications & Networking Devices, X-ray, CT, MRI, etc.

SMART HEALTH JAPAN Exhibitors include experts in the fields of: wearable devices, apps, software, OS, interface hardware, health entertainment, wireless technology, telecommunication equipment, telecommunication carriers, integration, procurement electronic components and OEM products, etc.

power saving technology, security systems, security cameras, GPS, cloud service, smart hospital technology, technology for ultra-aging societies, healthcare management service/facility/ technology, smart homes, AI, manpower services, hursing human resource development services, and medical equipment/technology for disasters.

TEST KIT JAPAN Exhibitors include experts in the fields of: finished products, manufacturing technology, parts and materials for testing kits such as blood test kits, influenza test kits, allergy test kits, STD test kits, cancer test kits, DNA test kits, etc.

CARE/WELFARE ROBOT & DEVICE EXPO Exhibitors include experts in the fields of: finished manufacture and development of care support robots & machines, communication robots, rehabilitation and welfare devices, etc.

MEDICAL CITY Exhibitors include experts in the fields of: connected services/technology, wifi services/technology, telecommunication service/technology, signal, WWW.MEDICALPLASTICSNEWS.COM

MEDTEC JAPAN IS DIVIDED INTO NINE SPECIFIC AREAS: Plastics technology Metal processing and machine tool Measurement and inspection Robots & mechatronics Packaging/sterilization/disposables Cad/Cam/RP Consulting Bionics technology area Security

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A brave new world

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DRUG DELIVERY

CHRISSY BELL, GLOBAL BUSINESS LEADER, 3M DRUG DELIVERY SYSTEMS, LOOKS AT WHAT THE DIGITAL REVOLUTION IS DOING FOR DESIGN AND COMMERCIALIZATION IN DRUG DELIVERY.

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oday, patient empowerment is at the center of the conversation surrounding healthcare and drug delivery technology. By using technology to augment existing care and provide the tools to allow patients to better manage their own conditions, we may empower patients to take back control of their own health, through the use of data and other insights.

SOLVING PROBLEMS With the arrival of new technology, we have the ability to address problems that have persisted for decades without a solution. For example, for patients suffering from asthma and chronic obstructive pulmonary disease (COPD), inhalation therapy hasn’t changed much in the last 50 years. Meanwhile, studies have shown that a vast majority of patients aren’t using their inhalers correctly or simply not using them at all.

By building technology into drug delivery devices, we can help address those problems. For example, the 3M Intelligent Control Inhaler, which is currently in development and not available for commercial sale, is breath-actuated so that patients do not have to coordinate their in-breath with triggering of the device.

It can provide feedback and tips on the user’s technique to encourage and promote correct use. The device can also send reminders to a patient, to help empower patient adherence.

The benefits of this technology may not only improve patient outcomes, it may also drive down healthcare costs, which is one of the major factors driving technological advancements in the healthcare industry.

We know preventive care saves money. By getting a drug more effectively and efficiently into a patient, we may prevent costly doctor visits, hospital stays, etc. I firmly believe that empowering patients in this way is key to reducing healthcare costs in the long term.

GAINING TRACTION While technology makes it possible to collect real-time data on a patient’s condition, in order to gain traction, innovations in drug delivery need to go beyond that.

The days of data dumps without guidance on how to take action are behind us. We have to help a patient understand what the data means and how to use it. The focus needs to be on action-oriented devices that help coach patients to better outcomes.

Another factor that will help new drug delivery innovations gain traction is in the design phase. As scientists and engineers begin drafting new designs for drug delivery methods, they are now starting with the patient at the ground level and working their way

up. That has not always been the case, and it has caused a disconnect that has inadvertently left patient circumstances out of the equation. The benefit of this new approach is the ability to first understand patient circumstances and the challenges they present.

Technology makes it easier to address those issues on the front-end, with the goal to increase better results on the back-end.

GOING MAINSTREAM As high-tech drug delivery devices arrive on the market, we need to make sure patients and their healthcare providers are willing to embrace them. Whenever new technology is introduced, growing pains are inevitable.

Learning how to use a new device takes time. It is a short-term investment for long-term gains of efficiencies and improved care, but, in their busy day-to-day lives, patients and providers may not always see it that way.

Due to these factors, when developing a new drug delivery technology, we must include input from patients and providers at all stages of development and make the process as easy for them as possible. When we talk to doctors, they tell us that sometimes technology is one more thing standing between them and their patients.

Our challenge is to make sure digital drug delivery devices help the doctor-patient relationship, rather than hinder it.

Another challenge facing the digital drug delivery industry is high-profile security breaches. People are already cautious about sharing their personal information in the digital space. When it comes to sharing something as private as their health data, patients have reason to be reluctant. It is incumbent upon us to prove they can trust us.

Gathering that data may do more than just help individual patients. As we begin to aggregate patient data, we’ll be able to capture population trends for the first time. Those trends will open up insights and uncover information that may ultimately create better treatment plans that may result in better outcomes for the patient population as a whole. I think we’ll really feel the impact when patients begin to realize that sharing their own data benefits the greater good.

CONCLUSION It is truly a time to be excited and optimistic. We are on the cusp of the digital revolution of healthcare. There is so much opportunity to improve the lives of patients and potentially fix problems that we know exist within our healthcare system. I believe, over the next five years, we’ll see that shift happen right before our eyes.

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Flow Sensor Platform For Respiratory Applications Sensirion‘s flow platform SFM3xxx includes sensors for inspiratory, expiratory and proximal flow measurement as well as gas mixing in ventilation and anesthesia appli­ cations. With the platform, the sensor manufacturer offers its customers the right sensor for all flow measurements and underscores its worldwide expertise in the field of medical ventilation.

Visit us: MD&M West 2019, Booth 1556

www.sensirion.com/medical

DRUG DELIVERY

MAKING ADVANCES DAVE GRAY SPEAKS TO PASCALE FARJAS, GLOBAL CATEGORY MANAGER FOR EAR, NOSE AND THROAT, AND BENOÎT GUILLARD, SENIOR DESIGN ENGINEER, AT DRUG DELIVERY EXPERT NEMERA, TO FIND OUT HOW TO DESIGN A DRUG DELIVERY DEVICE FOR OPTIMUM PATIENT COMPLIANCE. DG: What are the design considerations to ensure a full dose is delivered for each actuation?

PF: First, we need to make sure the nasal spray pump delivers the dose with a full stroke regardless of patient age or how the patient uses Advancia. This is achieved via a user-independent feature: at the beginning of the pump stroke, a stiff point is felt making the patient apply the required force to perform the full stroke of the pump in one unique movement. This full stroke enables the full delivery of the content of the chamber dose, with high precision and consistency.

DG: What measures did you take to ensure regulatory compliance?

BG: Advancia PF is compliant with EP/USP standards, and with applicable regulation for nasal sprays which I will not detail here. We are currently finalizing validation of sterility according to ISO 11137.

DG: What were the human factors engineering considerations in designing this product?

PF: Engineering considerations during Advancia development were based on our marketing brief. On the performance side, the unique selling point of Advancia is user-independence. On the design side, ergonomy and convenience were the key drivers of our engineers. For instance, the full overcap of the snap-on version is here to respond to a triple need: hygiene while protecting the actuator, nomadic use for transport in a bag or pocket, and no accidental actuation during transport.

DG: Tell us about the design of the mechanical closing tip PF: The objective of such a closing tip is to avoid any contamination through the orifice and clogging of the tip. How does it work? Purely mechanically: at rest position, the tip seal is closed under a spring force. Tip seal opens during spray delivery as bulk pressure exceeds closing spring force. After dose expulsion bulk pressure reduces and tip seal is closed immediately.

DG: How does the design ensure better compliance?

BG: Better compliance is achieved through the different design features of Advancia PF. It relies on a new pump engine technology, with a userindependent feature. What does that mean for the patient? On a userperspective, the patient feels like having the full dose delivered due to Advancia’s actuation profile. On the performance side, the dose is 100% delivered, with high precision and consistency through product life. No matter how the patient uses Advancia, they will have the full dose delivered each time.

DG: Why is it important to have no interaction between metal parts and formulation?

BG: Some drug formulations and/ or active ingredients can oxidize in contact with metallic parts.

Hence the active ingredient could lose its therapeutic efficacy or even become toxic. Moreover, these oxidation reactions also alter and degrade these metallic parts, thus liberating toxic particles for the brain. Last but not least, some deterging agents can be used during the manufacturing process of metallic parts, with the possibility to migrate into the drug formulation. That’s why, in general but for some drugs in particular, it is recommended the fluid pathway is metallic-free.

DG: Why did you decide on a onestep assembly version?

PF: Snap-on is the standard today for preservative-free nasal pumps.

In order to differentiate our product on the market, Advancia has a patented specific snap-on system, with a full overcap, allowing a onestep assembly during drug filling.

This new feature is intended to facilitate device assembly onto different containers (plastic or glass). Indeed, the assembly force required to snap the Advancia system onto the bottle is very similar from one bottle to another, as opposed to standard snap-on systems where the bottle neck design can have a high impact on the assembly force profile.

The mechanical closing tip avoids evaporation & clogging issues, which ensures the patient to have a spray for each delivery.

The anti-actuation overcap avoids any accidental spray delivery when transported in a purse or a pocket. Moreover, its hygienic overcap protects the actuator from dust/ external environment, which reassures the patient and corresponds to the patient lifestyle for a nomadic. Hence the patient can transport their nasal spray very easily for using it during the day, all that increasing patient adherence.

DG: What is PureFlow technology?

BG: PureFlow Technology is a patented technology developed by Nemera, which consists of filtering air entry by permeation through a silicone membrane. Air ingress is then sterile, without having any filter.

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Asia s largest tradeshow & conference dedicated to the design & manufacture of medical devices

18 th

Mon

20 th

Wed

2019 March

Tokyo, Japan @Tokyo Big Sight, East Hall Held at the same time Exhibition

Medical Electronics Expo

Medical ICT / Home Healthcare Expo

Care Welfare Robot & Device Expo

Test Kit Expo

www.medtecjapan.com

Secure Your Stand Now UBM Japan Co Ltd Tel：+81-3-5296-1034 Email : medtecjapan@ubm.com

COATINGS

FINISH THE JOB JAY TOURIGNY, SENIOR VICE PRESIDENT OF MICROCARE MEDICAL EXPLORES HOW THE TREND TOWARDS MINIATURIZATION IS AFFECTING COATING AND FINISHING DECISIONS.

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hile the healthcare industry has had a long-standing reputation of being slow to adopt change, there’s been a recent shift that’s brought about new innovative thinking. One example where this is prominent is within medical device design. Patients have been demanding smaller and more portable devices which has created new challenges for designers and engineers. They must now consider new options and application methods for product finishing, as well as how to properly clean them to meet the strict guidelines.

INNOVATIVE CLEANING OFFERS A SOLUTION It’s important that the cleaning methods of medical device components meet the highest standards of cleanliness as it can impact device performance and ultimately, any steps in the finishing process. This can be challenging as some traditional processes like water cleaning, for example, can leave behind spots. Also, water’s high surface tension inhibits its ability to reach, and therefore clean, small interior and intricate spaces.

LUBRICANTS TO MANAGE STACKED TOLERANCES Guaranteeing device performance is important, equally as important is knowing that the lubricating material will not migrate into the human body.

Many medical device manufacturers are finding great success with using polytetrafluoroethylene (PTFE), or “dry” lubricants, as opposed to traditional silicone lubricants as it stays on the instrument and does not transfer to the patient. It also can lubricate for multiple actuations and can be annealed to the instrument (substrate) so that it is semi-permanent. PTFE also can effectively address the issue of stiction (the combination of sticking and friction). Some surgical and medical procedural equipment is actuationbased, such as surgical staplers. This increases friction and mechanical movement requiring lubrication to eliminate stiction to ensure continued smooth movement.

Also, recent design incorporates single use devices created to be minimally invasive to the patient.

These however are more complex with many small parts. The higher the part count, the more likely ‘stacked tolerances’ will become an issue. This occurs when the tolerances of individual components “stack up” against each other and effect the performance of the device. Stacked tolerances can also be commonplace when dealing with multi-part mechanical assemblies with moving parts. One option to address this is to design everything with tighter tolerances; however, this results in higher production costs. Alternatively, lubrication can be used on the components to reduce movement friction and minimize actuation forces.

FINISHING TOUCHES The changes in medical device design have created new challenges and opportunities for innovative finishing options. There are now more application methods which are solving these problems: � DIPPING: Frequently used in high volume production, the benefits include consistency and uniformity in coating nearly any external and internal surfaces.

Small parts, coils of wires and unique geometries can be coated via this method.

• WIPING OR BRUSHING: Covering longer, ongoing surfaces including rods, tubing or sheeting can be accomplished through wiping or brushing. It can also be used if only small, select areas of a larger part requires coating.

• SPRAYING: Requires equipment such as a hand-held spray gun or automatic spray heads to apply diluted dispersions. Spraying can be used on a variety of devices.

It is also more selective than dipping since material can be applied to small areas with more precision.

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Precision Every Step Of The Way Our full design, manufacturing and assembly capabilities create total value solutions leading to cost improvement, reduced investment, and increased efficiency.

Carclo Technical Plastics specializes in injection molding and contract manufacturing services. Manufacturing includes cleanroom environments, automation, and assembly services for diagnostic disposables, respiratory, blood management, ostomy, ophthalmic, women’s healthcare, and surgical products.

www.carclo-ctp.com 724-539-6989 sales@carclo-usa.com United States | United Kingdom | Czech Republic | India | China

PACKAGING

Thermoforming player EXPANDS INTO THE MEDICAL DEVICE ARENA DORDAN MANUFACTURING, AN ILLINOIS-BASED CUSTOM THERMOFORM DESIGNER AND MANUFACTURER, IS CURRENTLY BUILDING A CLASS 8 CLEANROOM, SIGNALING AN EXPANSION INTO MEDICAL DEVICE PACKAGING. ISO 9001:2015 certified for the design, manufacture, and distribution of custom thermoformed products and packaging, and ISO 13485 Certificationpursuant, Dordan says it looks forward to “offering its nearly six-decades of thermoforming excellence to medical device designers, manufacturers, and contract manufacturers”.

Dordan President & CEO Daniel Slavin explains the strategy behind its diversification. According to Slavin, who runs the family business with his sister and, how this goes hand-in-hand with its approach to building a cleanroom onsite, rather than conforming to the industry trend of acquiring a medical thermoformer, or building an offsite facility: “There are many things to consider when diversifying into a new market.

That which is paramount, however, is the ability to maintain the corporate culture and continued investment in core capabilities. As a privately held family-owned and operated company, we offer the medical device market an assurance of corporate longevity, transparency, and integrity. While M&A fueled by equity funds continues to change the face of thermoforming – favoring short-term gains over long-term growth while disintegrating the culture – we remain focused, investing in that which makes us great in order to facilitate the success of the company for generations to come.

a soft wall modular cleanroom that maintains an ISO 9001:2015 Certified QMS, it is not in our nature to take shortcuts when it comes to participating in our customer’s success.”

Dordan Manufacturing’s core capabilities of engineering-centric thermoform designs and highquality thermoforming positions the company as an appropriate suitor for medical device manufacturers and their supply chain partners.

With a diverse clientele ranging from automotive OEMs to international luxury brands, Dordan is equipped with the foundation for entry to the medical device industry.

Dordan’s ISO Class 8 Cleanroom to be operational spring 2019.

“Our decision to build a fully enclosed cleanroom onsite utilizing hardwall construction is fueled by this corporate culture of pride for who we are and passion for what we do. We have always done things with the goal of contributing to our customers’ success. Thus, we feel as though maintaining critical quality through risk mitigation is best managed within our existing full-service and onsite thermoforming ecosystem; using our established quality management system as the springboard off which we pursue ISO 13485 Certification. While we have the ability to thermoform packaging for FDA Class 1 medical devices within Third-generation company operators and owners, brother-and-sister duo Aric (left) & Chandler Slavin

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PEEK & HIGH PERFORMANCE POLYMERS

PEEK has yet to peak AS MATERIALS SPECIALIST VICTREX NOW CELEBRATES THE 40TH ANNIVERSARY OF PEEK, INVIBIO IS MAKING SIGNIFICANT PROGRESS WITH ITS IMPLANTABLE PEEK, PROVIDING NON-METAL SOLUTIONS FOR IMPLANTABLE MEDICAL DEVICES. MPN RECENTLY HAD THE OPPORTUNITY TO TALK WITH JOHN DEVINE PHD, BUSINESS DIRECTOR AT INVIBIO BIOMATERIAL SOLUTIONS, TO ASSESS THAT PROGRESS.

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n 1978, PEEK (polyetheretherketone), a member of the PAEK (polyaryletherketone) family of high-performance polymers, was invented. Beyond the tongue twisting names are materials with significant properties.

These exceptional polymers have come to play an important role in replacing metal within several sectors, including automotive, aerospace and energy. The first commercialization of the new polymer came in 1981, in the form of Victrex PEEK. In 1993, a company called Victrex was formed around these polymers, focusing on the development of the PAEK family, and in particular PEEK – new materials that clearly had an enormous potential.

The focus sectors now include the medical field.

In 1999, PEEK-OPTIMA Natural was launched as the world´s first implantable PEEK polymer, which resulted in the manufacturing of an intervertebral cage – in other words, a spinal implant. The rest, as they say, is history.

That spark of innovative genius was instrumental in the formation of Invibio Biomaterial Solutions in 2001.

Operating as a division within the Victrex group of companies today, Invibio continues to actively pursue R&D and forge partnerships as it develops the potential of PEEK as an alternative to metal in spinal fusion, trauma, orthopedics (total knee replacement) and even dental prosthetics. Today, Victrex and Invibio remain ardent pioneers of PEEK, with a long track record of impressive achievements.

PEEK-OPTIMA Knee. This product is not available for implantation or distribution.

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MPN: PEEK’s 40th anniversary seems a good time to assess the impact of the high-performance polymer on the medical field. We know that Invibio’s PEEK is now being used to make implantable medical devices, for example. What are your thoughts on the future of PEEK as a material for medical implants?

JD: Over the last 15 years we have made enormous progress in the use of PEEK-OPTIMA-based solutions for medical implants, and we are absolutely sure this will continue to be the case. In spinal fusion, our PEEK-OPTIMA Natural has become one of the leading interbody fusion (IBF) biomaterials. Today, its many advantages, including a modulus similar to cortical bone, as well as radiolucency for artefact-free imaging, are maintained with PEEK-OPTIMA HA Enhanced, where hydroxyapatite (HA), a well-known osteoconductive material found within bone, is fully integrated, encouraging bone ongrowth.1 Similarly, for the treatment of trauma, Invibio has developed PEEK-OPTIMA Ultra Reinforced, which combines the mechanical properties of PEEK-OPTIMA Natural with the additional strength imparted by continuous carbon fibers. Compared to metals typically used in anatomic trauma plates, PEEK-OPTIMA UltraReinforced may offer earlier and greater callus formation for improved secondary bone healing,2 greater material fatigue life allowing healing to occur before the implant fails,3 and all the advantages of radiolucency for 360° fracture visibility during and after the procedure.

The PEEK-OPTIMA Knee Implant, meanwhile, has the potential to offer surgeons an alternative to metal implants for total knee replacement (TKR). Together with Maxx Orthopedics, we are progressing this program and fully expect it to contribute, in the long term, to improved operative procedures and economic and patient outcomes, with the potential to improve the patient’s quality of life.

Our vision for the future also includes the potential use of additive manufacturing techniques in the production of medical implants using PEEK OPTIMA. Victrex, our parent company, is currently cooperating with Exeter University in the development of VICTREX PAEK polymers for 3D printing processes and recently announced a high-strength PAEK-based material for

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PEEK & HIGH PERFORMANCE POLYMERS

laser sintering (LS), plus a filament with better Z-strength than existing PAEK materials and better printability for filament fusion (FF), although these are not currently available for use in medical implants.4 MPN: Can you highlight two or three clinical results that have unequivocally demonstrated positive patient outcomes?

JD: A summary of peer-reviewed published literature showed that the clinical history of PEEK in interbody fusion indicates that among comparative cervical interbody studies, fusion rates range from 88-100% for PEEK-OPTIMA Natural, while 47-93% fusion is achieved with titanium cages.6.7.8 Subsidence rates range from 0-14% of levels for PEEK-OPTIMA Natural, whereas it has consistently been reported as higher in titanium cage groups, from 16-20%.6.7.8.9 Odom criteria was available for three of the studies, demonstrating good or excellent outcomes in 64-80% of the patients receiving PEEK-OPTIMA Natural cages compared with 55-75% of patients receiving titanium cages.7.8.9 Cranio-maxillofacial studies have been conducted, on embedded cranioplasty (CP) and covered cranioplasty.

In one study, including 185 patients, the reoperation rate was lower (1.3%) and brain function improvement was higher (25.3%) with PEEK compared to titanium, where there was a high patient reoperation rate (10%) and lower brain function improvement (10.9%).10 In 2017, Alex Jahangir, MD presented results for a study using continuous carbon-fiber reinforced PEEK (CFR-PEEK) plates in the treatment of distal femur fractures.11 Distal femur fractures are most commonly treated with stainless steel (SS) or titanium lateral locked plating. CFR-PEEK plates are an alternative fixation, with a potentially higher fatigue strength compared to metal implants3 and a modulus of elasticity close to that of cortical bone. In a study of 38 patients, with an average age of 54 years, CFR-PEEK plates showed a similar time to radiographic union and full weight bearing as SS plates, with no hardware failures, reoperations, or non-unions in short-term follow-up. In contrast, while the patient population receiving SS implants was healthier, not all patients healed and plates broke. These data suggest that CFR-PEEK plates may be a viable alternative to SS plates in the fixation of these fractures11.

I think that these are three compelling examples of positive patient outcomes where PEEK-OPTIMA-based implant solutions have been applied.

MPN: Despite a wealth of increasingly convincing clinical evidence that PEEK-based devices can result in more favorable patient outcomes, metal implants remain the first port of call in many, if not the majority of cases. What challenges are you facing?

JD: Invibio is attempting an enormous sea-change, as we develop and supply PEEK-based devices. In this situation, progress is understandably gradual. Across all industries, driving innovation is challenging, but even more so in the medical field, for a variety of reasons.

This applies in particular to the smaller makers of medical devices, who may not have the resources to support sufficiently large and long-term clinical studies.

This is where Invibio can perhaps assist through some

JUVORA implant prosthetic framework

form of collaborative arrangement.

The social phenomenon of the diffusion and adoption of technological innovation is an interesting one. It’s been observed that the early adopters of innovative technologies and products are a minority. The vast majority in the community are slow to adopt change, even when it is clearly for the better. In the medical field, that’s compounded with the risk factors that are involved with the adoption of innovative products and practices.

It’s important for medical device manufacturers to address two questions. First, are they offering a solution to a significant medical problem? Second, in an era when medical costs are threatening to escalate out of control, can they offer a significant value proposition?

At Invibio, we are confident we are offering innovation as we partner with medical device manufacturers to deliver implants that have the potential to offer improved outcomes and quality of life for patients. We are also confident that the potential to reduce postoperative complications will save costs for healthcare systems. It’s this conviction that gives us the resilience to keep driving innovation into the market.

MPN: I understand there is also a prosthetic solution for use in dentistry, the JUVORA dental disc, made from Invibio’s PEEK-OPTIMA, and that this is now under long-term study. What would you say is the likely future role of PEEK prosthetics in dentistry? Is this yet another example of PEEK’s versatility?

JD: The JUVORA disc is CAD/CAM millable, so it can be used with all the advantages and efficiency of digital workflows. We expect computerized design techniques to have an increasing impact on PEEK-based implants and prosthetics, in dentistry, and quite possibly in other medical fields.

Dental clinician Bernd Siewert, at the Clinica Somosaguas, Madrid, has used the JUVORA disc extensively, evaluating patients long-term as his practice moved to fully digital workflows and a current thirdgeneration of JUVORA-based prosthetics, reducing manufacturing time while delivering all the benefits of implantable PEEK. Very positive findings at the Clinica Somosaguas, obtained from 21 patients with full-arch implantsupported screw-retained bridges on a PEEK framework, certainly indicate that PEEK has a potentially major role to play in the field of dental prosthetics due to its excellent biocompatibility and the many advantages of being metal-free. In this particular study there was no corrosion, and healthy soft tissue was maintained.12 References 1-12 Supporting information available upon request from Invibio Biomaterial Solutions for all claims.

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PACK YOUR BAGS IT’S AN EXCITING TIME FOR THE MEDICAL PACKAGING INDUSTRY, WITH MANY NEW PRODUCTS ENTERING THE MARKET THAT DEMAND MULTIFACETED PACKAGING. PHARMAPACK EUROPE, HELD IN PARIS THIS FEBRUARY, WILL BE A MEETING OF MINDS FOR THOSE LOOKING FOR A NEW APPROACH.

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ew packaging regulations have led to contract packaging organizations taking a more significant role in producing advanced packaging and drug delivery solutions.

Pharmapack Europe will take place 6-7 February 2019 at the Paris Expo, Porte de Versailles, France.

This year, Pharmapack is expected to play host to over 410 exhibitors and 5290 attendees from more than 100 countries over two days, making it the most international edition to date.

The conference agenda will consist of a two day programme delivered by high-level industry expert speakers discussing current pharmaceutical packaging market trends, along with an overview and analysis on regulatory changes in the EU and US markets. Some of the major topics will include: patient adherence, challenges in usability, regulatory updates, biologics and biosimilars, drug delivery devices, sustainability, and devices.

Highlights from the conference agenda include Dr Alex Cole of the CPI, who will discuss the future of smart pharmaceutical packaging and smart medical devices. The agenda also includes an entire session devoted to new packaging materials and drug delivery systems, as well as a session on the challenges and solutions when developing a custom primary container.

The 2019 Technical Symposium, designed to promote exhibitors, will provide insight from pharma industry leaders on tackling the challenges and technical problems associated with novel approaches. This will include case-studies on pre-filled on body Injectors, drug-device combinations, drug repurposing, glass pre-fillable syringes, QBD and nasal delivery innovations.

Additionally, this year, sustainable approaches to medical plastic packaging will be a topic of discussion.

To celebrate, at the center of the show will be the 2019 Start-up Hub, providing a platform dedicated to emerging new and innovative technologies in the fields of pharmaceutical packaging, labeling, drug delivery device design and engineering. Exhibitors here will showcase product innovations and take part in the Start-up Pitch – retained from last year, this opportunity gives exhibitors the chance to pitch their company to a panel of experts in front of a live audience of industry professionals.

Finally, the International Meetings Programme is a complementary online service provided by goMed2Med that enables all attendees to pre-arrange mutuallybeneficial meetings at the event.

Meetings can be arranged to take place either in the International Meeting Lounge – stand G70 – or on the exhibitor’s stand.

Pharmapack Europe 2019 will take place 6-7 February 2019 at the Paris Expo, Porte de Versailles, France Paris.

The 2019 edition of Pharmapack will also feature the Learning Lab, situated directly on the exhibition floor, it is designed to inform visitors on the latest exhibitor products and services. Session highlights include a presentation from by Hiroki Hasegawa, researcher at Mitsubishi Gas Chemical Company, on the best plastic vial & syringe for oxygen sensitive drugs and a talk from Arnaud Guillet, business development director at Biocorp on how smart devices are changing drug delivery.

The Pharmapack Awards will be hosted alongside Pharmapack Europe 2019 and will celebrate the latest innovations from the pharmaceutical packaging industry. The awards have two categories – health products and exhibitor innovations. Each are judged by a panel of independent industry experts and decision-makers, and the awards will be presented on 6 February.

Last year’s awards saw an influx of entries of exceptional calibre. All exhibitor innovations submitted for the Pharmapack Awards are showcased in the Innovation Gallery, which gives a comprehensive overview of recently launched products. Moreover, there will also be hour long guided Innovation Tours, delivered by industry experts, to highlight exceptional exhibitors throughout the innovation gallery.

WWW.MEDICALPLASTICSNEWS.COM

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EXTRUSION

Film stars US PLAYER TEKNI-PLEX RECENTLY ACQUIRED BEYERS PLASTICS, A CLEANROOM CLASS 7 EXTRUDER AND CONVERTER OF POLYETHYLENE (PE) FILM, FROM BELGIUM. DAVE GRAY CAUGHT UP WITH MICHIEL VAN DEN BERG, DIRECTOR, GLOBAL PHARMACEUTICAL DEVELOPMENT FOR TEKNI-PLEX’S TEKNI-FILMS BUSINESS UNIT, TO FIND OUT WHAT THIS MEANS FOR BOTH FIRMS.

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eyers will now become part of Tekni-Plex’s TekniFilms business unit. It specializes in producing PE packaging for pharmaceutical, medical and other industries such as food, aerospace, solar energy, semiconductor and chemicals.

The Beyers Plastics purchase is the tenth acquisition Tekni-Plex has made in the past four years, supporting its strategy to grow its business through transformative acquisitions and strategic add ons.

DG: What new technical capabilities does the Beyers Plastics acquisition bring?

With the acquisition of Beyers Plastics, Tekni-Plex is adding cleanroom blown film extrusion to its film manufacturing portfolio for pharmaceutical and medical applications. Blown film extrusion is the preferred polyolefin film production technique to achieve thicknesses required for bags and drum liners. These are used to package pharmaceutical bulk products or molded components used in pharmaceutical delivery or medical devices. Beyers Plastics is also converting blown films into bags by sealing to customer-specified dimensions. These bags are considered primary packaging components for pharmaceutical and medical applications and are regulated as such. These capabilities are new to Tekni-Plex, making Beyers Plastics our global center for blown film and bag sealing.

DG: What are Beyers’ core strengths in medical extrusion?

Pharmaceutical and medical bags and films have similar strict regulatory requirements. With film extrusion and bag sealing under one operation, Beyers Plastics controls the entire process from film composition, cleanroom standards, weld seal performance and dimensions. Additionally, the finished goods can be sterilized upon request of the customer.

DG: How common is it to find a class 7 PE film extruder on the market?

Cleanroom made PE film is quite common in the healthcare industry. The requirements of the pharmaceutical and medical manufacturers for cleanroom films are currently serviced by many converting companies, just like Beyers Plastics, who specialize in producing these materials.

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DG: You also have expertise in tubing extrusion for medical applications - can you elaborate on that side of the business?

Tekni-Plex has two business units that manufacture tubing for medical applications—Natvar and Dunn Industries. Collectively, these businesses extrude a variety of tubing sizes and configurations from a wide range of materials, including polyvinyl chloride (PVC), thermoplastic elastomers (TPE), thermoplastic polyurethane (TPU), polyamides, polyolefin, and much more.

Natvar is an innovative global supplier of medical tubing solutions for a broad spectrum of medical device products that target hospital, physician, dental healthcare and in-home use. Its global footprint is supported by five manufacturing facilities located in the United States, Costa Rica, China and Belgium.

Natvar’s precision-crafted tubing solutions are used by leading medical device companies around the world for applications such as intravenous therapy, dialysis, cardiac surgery and many others.

Acquired earlier this year, Dunn is a leading global supplier of extruded tubing used in medical device applications. Custom tubes are available for prototype development and full-scale manufacturing of advanced catheter shaft assemblies and minimally invasive device components. Dunn also manufactures solid polymer cores used to retain inner lumen dimensions during the manufacture of advanced catheter shafts.

DG: What are the trends you’re seeing in film and tubing extrusion?

Globalization of medical device design, development and manufacturing is requiring film and tubing companies to expand services in new geographies.

For example, device companies in China and Brazil are increasingly designing and developing products for their local market. Meanwhile, device manufacturing continues to migrate to more economical regions in Southeast Asia and Central America. Suppliers must be able to provide technical support and prototypes quickly during early stage development at new design locations, while offering timely delivery of quality products at new production locations.

WWW.MEDICALPLASTICSNEWS.COM

EXTRUSION

Additionally, medical device regulations continue to develop and change in emerging regions, such as China and India. Medical film and tubing suppliers must be able to comply with a broader range of global regulatory requirements, such as contamination controls and validations.

DG: What are common challenges in medical device packaging, and how can Tekni-Plex’s business support this?

Similarly to pharmaceutical companies, medical device companies are continuously being challenging to meet both performance and cost objectives. For example, Tekni-Plex’s Tekni-Films business unit has developed its TekniMD PX film series as a drop-in, cost-effective replacement to PETG for thermoformed medical tray packaging.

We have seen the development pipeline increase twofold over a year ago, with activity both in the United States and Europe. The material is gaining traction globally in a number of sterile barrier tray applications whose companies want a cost-effective alternative to PETG for products such as orthopedic devices, prefilled syringes and infusion assemblies and tubing.

Challenges in endovascular tubing can often be associated with new designs to reach distal regions within the body and/or provide novel interventions. In many cases, this requires catheter tubes with smaller diameters, wall thicknesses and tolerances. Designers of these devices require companies that can provide tubes quickly for evaluation of early stage prototypes.

Dunn has an extensive library of extrusion tooling and materials that facilitate rapid development of small single-lumen and multi-lumen tubes with tight tolerances, such as those used in neurovascular microcatheters.

DG: Is widening your footprint in Europe a key part of your strategy going forward?

The Beyers Plastics purchase is the tenth acquisition Tekni-Plex has made in the past four years, supporting its strategy to grow its global business through transformative acquisitions and strategic add-ons.

Tekni-Plex has a solid track record of successful business integrations, having acquired companies with innovative plastic and rubber products to further drive growth.

TekniMD PX films also are being specified for nonsterile totes and retainers that are used for work-inprogress transfers between different company facilities.

Additionally, the PX film line offers a wider processing window than PETG and bears recycling code #1.

DG: What are common challenges in medical tubing, and how can TekniPlex’s extrusion expertise support this?

Medical tubing challenges often differ by device type. For example, tubing used for medical pumps, blood management and respiratory devices, is often supplied in large quantities to exacting, repeatable standards.

Device companies often prefer suppliers with a global manufacturing footprint that offers validated tube extrusion in locations proximal to their manufacturing. Natvar manufactures tubing in five locations around the world, including North America, Central America, Europe and Asia. Each location is equipped with extensive quality management and validation resources for production.

WWW.MEDICALPLASTICSNEWS.COM

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JOIN NORTH AMERICA’S

LARGEST ANNUAL MEDTECH EVENT

MD&M West is the largest medical design & manufacturing expo and conference in the US, taking place in one of the largest hubs for medical device innovation in the world – Southern California.

• SOURCE from the world’s largest collection of medtech suppliers • CONNECT with engineers and executives who are ready to forge business partnerships • LEARN from industry luminaries presenting their insights

FEB 5-7, 2019 // ANAHEIM, CA

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The Anaheim mighty...

MEDTECH SHOW

TO MANY, IT’S FAMOUS FOR TWO THINGS: THEME PARKS AND A LEGENDARY ICE HOCKEY TEAM. BUT TO THOSE IN THE KNOW, ANAHEIM IS ALSO THE FIRST STOP IN THE CALENDAR YEAR FOR THE LATEST DEVELOPMENTS IN MEDICAL DEVICE INNOVATION. DAVE GRAY EXAMINES WHAT’S ON SHOW AT MD&M WEST 2019.

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or the plastics community, MD&M West has plenty to offer. In fact, the majority of the exhibitors there intersect with the market for plastic medical innovation, either directly or indirectly. Ineos Styrolution, for example, one of the key players in the materials market, will be at this year’s show, and while the firm says it will be focussing on digital health (it’d be mad not to) it will also be launching new grades for older applications.

One of the new grades on offer is targeted at medical tubing, including multi-layer tubes, and will be available with Ineos Styrolution’s Essential HD Package (risk class 1 & 2) with 12 months notification of change (NOC) with a signed long-term supply contract.

Teleflex Medical OEM will also be returning to Anaheim this year, with a host of new products on offer. First up is its new hydrophilic surface coating for polymer-based devices that are to be navigated through the vascular system. It reportedly demonstrates biocompatibility and shelf-life stability, exhibits low particulate count in testing, and boasts good adhesion to the substrate material. The coating can be customized to optimize certain performance characteristics based on specific user needs, says the firm.

The coating may reduce the required insertion force which may result in improved control, placement, and tracking of a device, says Teleflex Medical OEM. Applications for this surface technology include introducers, diagnostic catheters, balloon catheters, and components.

The coating is just one recent development from the group, which will also bring its new braiding technology which can divide a suture into multiple end branches or integrate several “loops” within the strand. This continuous braiding process can produce variations of complex, divided segments at the end of a suture, or between singular round or flat tape segments, says the group.

makeup (GC testing), thermal behavior (DSC testing), and viscosity and rheology behavior (IV testing).

MTD claims it is also the first company in North America to own a Mitsubishi MX600 oil wire EDM machine, which lets machining operators use ultra-small wire in the range of .0008”–.001”.

“The machine has doubled our wire EDM capacity and has made getting down to the smallest wire diameters much easier,” said operations manager, John Clark. “Although our lead time to build new tools is driven by the complexity of it and its components, on average, we were anywhere from six to eight weeks in production. Now, we can get components out to our customers in two to three weeks.”

MD&M West will take place 5-7 February at the Anaheim Convention Center.

The show floor will also play host to plenty of contract molders jostling for position. One group with something to shout about is MTD Micro Molding, which recently announced new investments that expand on its capabilities.

The firm’s new gas chromatography system for example is a piece of analytical equipment that can measure residual monomer and assist with material characterization, which further supports R&D projects by looking at materials on a molecular level. When used in conjunction with DCS equipment for material characterization, MTD can build robust profiles for materials to analyze behavior—crucial for manufacturing intricate components with critical medical functionality.

This provides an in-house suite of equipment for material characterization/science: molecular WWW.MEDICALPLASTICSNEWS.COM

35

Surgical company teams up with training center ahead of U.S. product launch CMR Surgical has teamed up with the Nicholson Center to train 27 surgical teams, including more than 100 healthcare professionals, and assisted in nine weeks of FDA validation studies ahead of the launch of Versius in U.S. – expected in March 2019.

Martin Frost, CEO of CMR Surgical said: “We are pleased to partner with the Nicholson Center to roll out a training program that introduces surgeons to Versius. Versius has been designed with the surgeon in mind and we are confident that by supporting the necessary training we can work with surgeons to realize the benefits of minimal access surgery for patients.”

Versius has a small form factor, modular design and individually cart-mounted arms. The product is designed to be easy to move between operating rooms and even hospitals or clinics, quick to set up and gives the surgical team easy access to the patient at all times.

36

‘STROKE SCANNER’ GETS BACKING, COULD SPEED UP DIAGNOSIS A medical device company has raised $6m (Aus) for technology to help stroke victims.

EMvision Medical Devices raised the capital following an oversubscribed initial public offering (IPO) and will be listed on the Australian Stock Exchange.

The company will develop a portable, non-invasive brain scanner in partnership with the University of Queensland, with the aim of speeding up the diagnosis of brain injuries and

stroke by creating 3D images of the brain, and with it not being reliant on the patient being taken to the imaging technology.

In the technology’s initial application, EMvision plans to use the device to monitor victims of stroke at their bedside while recovering and detect the onset of subsequent strokes – half of which occur within a week of the first stroke.

Future versions of the device are also expected to provide rapid stroke decision support

in ambulances, whereby patients having a stroke could be identified and transported directly to specialist hospitals for intervention.

Experts investigating new coatings for additive manufacturing Researchers from Sirris and the Fraunhofer Institute for Applied Polymer Research (IAP) have investigated technical coatings for additive manufacturing (TCAM) in a joint project, with results described as ‘promising’.

The two partners have concluded that additive manufacturing (AM) in combination with established technologies provides better capabilities and more possible applications than AM alone.

Additive manufacturing has many advantages such as custom manufacturing,

flexible production and easy customization. Yet many products have a high surface roughness and porosity. The post processing of the thus fabricated parts is time consuming and often a significant cost factor for manufacturers.

Technical coatings could open up possibilities for the market, especially in industrial production.

Patrick Cosemans from Sirris Flanders said:

WWW.MEDICALPLASTICSNEWS.COM

“If we only polish our finished components, it takes a long time, and especially with fine, detailed features, we change their shape.

It comes to abrasion, which we want to avoid. With the Fraunhofer (IAP) we have developed possibilities to overcome the current problems, especially the porous and rough surface, in additive manufacturing.”

2019 NORTH AMERICA EVENT CALENDAR

JAN 29-31, 2019 // SANTA CLARA, CA

AUG 27-29, 2019 // SANTA CLARA, CA

DesignCon

Drive World Conference & Expo, ESC

FEB 5-7, 2019 // ANAHEIM, CA

SEP 10-12, 2019 // NOVI, MI

ATX West, MD&M West, Pacific Design & Manufacturing, PLASTEC West, WestPack

The Battery Show, Electric & Hybrid Vehicle Technology Expo

MAY 15-16, 2019 // BOSTON, MA

OCT 23-24, 2019 // MINNEAPOLIS, MN

BIOMEDevice Boston, Design & Manufacturing New England, ESC

ATX Minneapolis, Design & Manufacturing Minneapolis, MD&M Minneapolis, MinnPack, PLASTEC Minneapolis

SANTA CLARA CONVENTION CENTER

ANAHEIM CONVENTION CENTER

BOSTON CONVENTION & EXHIBITION CENTER

JUN 4-6, 2019 // TORONTO, ON TORONTO CONGRESS CENTRE

Advanced Design & Manufacturing (ADM) Expo featuring PACKEX, PLAST-EX, ATX, Design & Manufacturing, Powder & Bulk Solids

SANTA CLARA CONVENTION CENTER

SUBURBAN COLLECTION SHOWPLACE

MINNEAPOLIS CONVENTION CENTER

DEC 4-5, 2019 // SAN JOSE, CA SAN JOSE CONVENTION CENTER

BIOMEDevice San Jose

JUN 11-13, 2019 // NEW YORK, NY

JACOB K. JAVITS CONVENTION CENTER

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